This is a twelve-month, open-label extension study. Patients will be assessed at the final visit of the treatment period of the proceeding protocol and must satisfy the eligibility criteria for entry into the study. Qualifying patients from the previous study will begin receiving 4 mg tablets to be taken twice daily, one tablet in the morning with breakfast and one tablet in the evening with a meal. The insulin dose may be adjusted after a period of two weeks in the open-label study. Patients are not permitted to take other antidiabetic medications for the duration of the study.